Sprycel
dasatinib
Table of contents
Overview
Sprycel is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
- chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
- CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases. Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
- Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast’ CML. Sprycel is used when other treatments do not work or cause troublesome side effects.
Sprycel is also used in children to treat:
- newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
- newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Sprycel contains the active substance dasatinib.
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List item
Sprycel : EPAR - Medicine overview (PDF/87.85 KB)
First published: 18/08/2009
Last updated: 29/03/2019 -
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List item
Sprycel : EPAR - Risk-management-plan summary (PDF/242.71 KB)
First published: 29/03/2019
This EPAR was last updated on 16/02/2021
Authorisation details
Product details | |
---|---|
Name |
Sprycel
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Agency product number |
EMEA/H/C/000709
|
Active substance |
dasatinib
|
International non-proprietary name (INN) or common name |
dasatinib
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01XE06
|
Publication details | |
---|---|
Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Revision |
35
|
Date of issue of marketing authorisation valid throughout the European Union |
20/11/2006
|
Contact address |
Plaza 254 |
Product information
17/04/2020 Sprycel - EMEA/H/C/000709 - IG/1223/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Therapeutic indication
Sprycel is indicated for the treatment of paediatric patients with:
- newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib.
- newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
Sprycel is indicated for the treatment of adult patients with:
- newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase;
- chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate;
- Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Sprycel is indicated for the treatment of paediatric patients with:
- newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.